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Correlation analysis of hepatitis C virus core antigen and low viral loads: Can core antigen replace nucleic acid test?

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Abstract

Value of hepatitis C virus (HCV) core antigen (cAg) test has been controversy in patients with low HCV loads for its lower sensitivity. We assessed correlation between HCV-cAg and HCV RNA in serum samples with low viral loads and analyzed the performance of HCV-cAg assay in determining diagnosis and treatment outcomes in chronic hepatitis C patients. Both HCV RNA and HCV-cAg were detected for 2298 serum samples. Correlation analysis was performed between the two tests. Receiver operating characteristics (ROC) curve was used to assess value of HCV-cAg test in determining diagnosis and response outcomes at the different HCV RNA thresholds. The two tests were correlated very well, and moreover, correlation in the low viral load group was higher than that in the high viral load group (r value: 0.901 and 0.517). Positive agreement of HCV-cAg ≥ 3 fmol/L was as high as 97.0% for HCV RNA ≥ 1000 IU/mL, and its negative agreement for HCV RNA < 15 IU/mL was up to 98.9% in all samples. Area under ROCs ranged from 0.939 to 0.992, regardless of HCV RNA thresholds. When lower limit of detection of HCV RNA was 15, 100 or 1000 IU/mL, positive predictive value of HCV-cAg was 96.8%, 98.8% or 92.4%, and its negative predictive value was 87.0%, 89.9% or 98.3%, respectively, on the basis of different cutoff values. High-sensitivity HCV-cAg detection may likely replace HCV RNA to confirm the existence of HCV and to guide the treatment of chronic HCV infection.

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Acknowledgements

The assistance of Abbott Diagnostics in the provision of the HCV core antigen kits for this evaluation.

Funding

Supported by Grants from National S&T Major Project for Infectious Diseases Control (2012ZX10002-003), National Major S&T Special Project for “Significant New Drugs Development” (2012ZX09303-019) and Beijing Medical & Health Technology Promotion Project (2018-TG-19).

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Authors and Affiliations

  1. Peking University People’s Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China

    Bo Feng, Rui-Feng Yang, Han-Ji Jiang, Yan-Di Xie, Hai-Ying Zhang, Qian Jin & Xu Cong

  2. Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Institute for Precision Medicine, Tsinghua University, No. 168 Litang Road, Changping District, Beijing, 102218, China

    Lai Wei

Authors
  1. Bo Feng
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  2. Rui-Feng Yang
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  3. Han-Ji Jiang
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  4. Yan-Di Xie
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  5. Hai-Ying Zhang
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  6. Qian Jin
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  7. Xu Cong
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  8. Lai Wei
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Contributions

Feng B contributed to design, data acquisition and statistical analysis and drafted the manuscript; Yang RF and Jiang HJ contributed to data acquisition and statistical analysis; Xie YD and Zhang HY participated in study design and data analysis; Jin Q and Cong X participated in study planning and statistical analysis; Wei L contributed to funding, design and critical revision of the manuscript; and all authors read and approved the final manuscript.

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Correspondence to Bo Feng or Lai Wei.

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The authors declare that they have no conflict of interest.

Ethical approval

This study was performed according to the guidelines of the International Conference on Harmonization for Good Clinical Practice and the ethical guidelines of the 1975 Declaration of Helsinki. The study protocol was approved by the ethical committees of Peking University People’s Hospital.

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Informed consent was obtained from all individual participants included in the study.

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Feng, B., Yang, RF., Jiang, HJ. et al. Correlation analysis of hepatitis C virus core antigen and low viral loads: Can core antigen replace nucleic acid test?. Clin Exp Med 20, 131–141 (2020). https://doi.org/10.1007/s10238-019-00588-1

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  • DOI: https://doi.org/10.1007/s10238-019-00588-1

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